FDA.reportPublic FDA data

Application 040836

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL1MGNoNo
002GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1250GlycopyrrolateGlycopyrrolateWest-ward Pharmaceutical CorpANDACurrent
0143-1251GlycopyrrolateGlycopyrrolateWest-ward Pharmaceutical CorpANDACurrent